Medical Devices & Supplies Control Section

Public



A:
  • The person who experienced the problem.
  • A relative or guardian of the person concerned.
  • A representative chosen by the person concerned for the purpose of making the complaint.
  • A health service provider.
A:A complaint must be received in writing using the Complaint Form through:
  • Personal attendance
  • Mail
  • Email (complaints@nhra.bh)
  • The national suggestions and complaints system (Tawasul) on e.Government portal(www.e.gov.bh)
A:
  • A completely filled Complaint Form.
  • Any extra information and copies of other relevant documents should be attached to your written complaint.
A:NHRA cannot accept a complaint from an anonymous source due to seriousness considerations and confidence in the medical system, but NHRA can upon request keep the complainant’s data confidential for reference at the time of need if possible.
A:
  • Practitioners such as doctors, nurses, dentists, pharmacists, physiotherapists, paramedics and other allied health professionals regulated by the NHRA.
  • Health service facilities such as public or private hospitals, clinics, medical centers, day surgery centers, the Ambulance Service and others, affecting the clinical care or treatment of an individual.
  • Complaint can be about the health service provider professional conduct and/or the clinical care and treatment provided or fitness to practice.
A:There are no fees when making a complaint.
A:It can be download from our website (www.nhra.bh) under complaints, or sent to you by email. You can also get a copy by personal attendance to our premises.
A:Our staff can help you put your complaint in writing, if you require assistance.
A:Once the NHRA receives your complaint, it will be assessed and if it is not within the jurisdiction of NHRA you will be notified and directed to the appropriate authority if possible. If the complaint is within the NHRA jurisdiction, you will receive an acknowledgment letter which will include the number assigned to your complaint. The NHRA will obtain all relevant information including a copy of your medical record and a report from your health care provider, internal/external Professional Advisors and committees may be needed to review your complaint to reach a decision. Once a final decision is made you will be notified of the result.
A:There is no specific time frame in which complaints are resolved. Once a complaint is received, it will be reviewed and the necessary information to evaluate the complaint will be gathered. It may take several months to review and/or resolve depending on the nature of the complaint.
A:It is not within the jurisdiction of NHRA to consider any claims for compensation. NHRA role lies in determining the medical error and the disciplinary punishment for health professionals. Should you wish to pursue compensation, you can appeal to court.
A:The NHRA cannot compel a health service provider to alter their fees or make any recommendations in relation to their fees. The NHRA cannot compel a health service provider to provide you with a refund. Should you wish to pursue a refund, you can seek legal advice or contact the Consumer Protection Directorate of the Ministry of Industry and Commerce.
A:Can the NHRA change what is written in my medical records?
A:NHRA cannot provide treatment nor give recommendations regarding alternative health providers.
A:A health service provider is required to provide treatment in an emergency situation. However, in non-emergency situations a health service provider can refuse to treat you, provided that his decision does not contradict with medical practice or ethics. You can file a complaint in situations where you think you were refused medical treatment with no justification.
A:If you decided to withdraw your complaint, you have to submit a signed Complaint Withdrawal Form. However, NHRA reserve the right to continue investigating the complaint if it represents a significant issue of public health or safety and entails a medical error or a violation of medical practice ethics or regulations.
A:A complainant cannot submit an appeal to NHRA decision. In case of dissatisfaction with the decision you may approach the judicial authorities in the Kingdom
A:The complaint file, and all related documents, reports and investigations proceedings are kept confidentially in NHRA. It is not permitted to release any document related to the investigation to any party including the complainant except through an official request from the judicial authorities in the Kingdom.
A:
  • Management of the health care facility where you received treatment.
  • Consumer Protection Directorate of the Ministry of Industry and Commerce (click here)
  • Ministry of Health (for non-regulatory concerns about a public health service) (click here)

Pre Market


First, before importing or registering medical devices, you must be registered as an authorized representative in NHRA by applying and obtaining a license to import and register medical devices.


Secondly, classify medical devices by making sure that they are listed under medical devices or other category by applying for classification.


Third, submitting an application to register medical devices to facilitate the importation process into the Kingdom of Bahrain by applying for registration of medical devices.

On Market

Controlling medical device importation at the ports of entry where importers must submit an application through Ofoq website and submitting the required documents to obtain NHRA approval before importing medical devices.

Regulating advertisements for medical devices based on Decision (48) 2020, Article (10) “It is forbidden for any person to market or advertise the medical device and product unless obtaining a license from the Authority.


Post Market

Decision (48) 2020, Article (16) intended to guide and encourage all healthcare facilities, importers, patients and professionals to the importance of reporting problems associated with medical devices, including:

Permit To Use

Field Safety Notice and Recalls

Adverse Events and complains


Medical Devices Destruction

Healthcare Facilities Inspection